Urinary incontinence, or the inability to control urination, is a major and debilitating problem affecting millions of people, especially women. The female""s natural support system for the urethra is a hammock-like supportive layer composed of endopelvic fascia, the anterior vaginal wall, and a distal attachment to the pubic bone. Weakening and elongation of the pubourethral ligaments and the arcus tendineus fascia pelvis, weakening of the endopelvic fascia and pubourethral prolapse of the anterior vaginal wall are some common characteristics of a patient with urinary incontinence.
Many procedures have been devised to treat urinary incontinence. Some have the goal of elevating the neck of the bladder to return it to a higher retropubic position. Many pubovaginal sling procedures have been developed to treat urinary incontinence. Some of these procedures involve positioning anatomical sling material under the urethra to provide elevation and support of the urethra and/or the bladder neck. Examples of attachment sites for the sling include the anterior or superior portion of the pubis (e.g. with bone anchors and associated sutures), Cooper""s ligament, or rectus abdominus fascia. Examples of procedures for treating incontinence are disclosed in U.S. Pat. Nos. 5,112,344; 5,611,515; 5,842,478; 5,860,425; 5,899,909; 6,039,686, 6,042,534 and 6,110,101.
Slings used for pubovaginal procedures differ in the type of implantable material and anchoring methods. In some cases, the sling is placed under the bladder neck and secured via suspension sutures to a point of attachment (e.g. bone) through an abdominal and/or vaginal incision.
Complications associated with procedures for treating incontinence include urinary retention, bladder instability and erosion of an implanted article into surrounding tissue. See Spencer et al, A Comparison of Endoscopic Suspension of the Vesical Neck With Suprapubic Vesicourethropexy for Treatment of Stress Urinary Incontinence, J. Urol. 137: 411, (1987); Araki et al, The Loop Loosening Procedure for Urination Difficulties After Stamey Suspension of the Vesical Neck, J. Urol., 144; (1990); and Webster et al., Voiding Dysfunction Following Cystourethropexy: Its Evaluation and Management, J. Urol., 144; (1990).
With respect to sling procedures, if the sling mesh is too loosely associated with its intended physiological environment, the mesh may be ineffective in supporting the urethra and treating incontinence. Several complications can arise from a mesh that is too tightly placed including retention, sling erosion and other damage to surrounding tissue such as the urethra and vagina.
The TVT Tension-free Vaginal Tape procedure utilizes a knitted Prolene(trademark) nonabsorbable, polypropylene mesh. The mesh is a substantially flat, rectangular woven article. The mesh includes a plurality of holes that are sized to allow tissue ingrowth to help avoid infection. A removable plastic sheath surrounds the mesh and is used during insertion of the mesh. The sling is positioned near the urethra without the use of bone anchors. Once the sheath is removed from the mesh of the TVT product, friction between the mesh and tissue keeps the mesh in position and it becomes very difficult to subsequently adjust the position of the mesh relative to tissue. Attempts to move the sling once the sheath is removed may damage the sling or adjacent tissue such as the urethra or vagina.
Proper tension of a sling is an important factor for a successful surgical procedure. Surgical approaches to applying tension or slack in a sling procedure vary widely. See Decter, Use of the Fascial Sling for Neurogenic Incontinence: Lessons Learned, The Journal of Urology, Vol. 150, 683-686 (1993). While the TVT procedure suggests using a scissors or hemostat placed between the sling and urethra to set the looseness of the TVT mesh sling, a flat blunt surgical instrument is placed between the sling and urethra in other procedures. See Moir et al., The Gauze-Hammock Operation, The Journal of Obstetrics and Gynaecology of the British Commonwealth, Vol. 75, No. 1 (January 1968) Pps. 1-9.
The TVT sling procedure instructs users to place a scissors or hemostat between the urethra and the sling to ensure ample looseness of the sling. There are several problems associated with this approach. First, the type of scissors or hemostat used to tension the sling may differ in size, potentially causing application of different amounts of looseness for the sling. For example, one surgeon may use a Mayo scissors while another surgeon may use a hemostat or flat, blunt instrument. It is believed that the use of different instruments with different sizes inherently leads to inconsistency in the amount of slack or looseness provided in a sling. This inconsistency could lead to inconsistent therapeutic results, misleading medical data and other clinical errors. Second, even if the same surgical instrument is used, the precise portion of the surgical instrument used to set the looseness of the sling may vary along the length instrument. For example, some surgeons use the tips of closed Mayo scissors to tension a sling. Mayo scissors are curved and the precise thickness of a scissors along its length varies significantly. See FIG. 5 of Rackley et al., Tension-free Vaginal Tape and Percutaneous Vaginal Tape Sling Procedures, Techniques in Urology, Vol. 7, No. 2, pp. 90-100 (2001). Depending upon how far the Mayo scissors tips are inserted between the sling and the urethra, the actual amount of looseness provided can vary significantly.
Other prior art sling procedures use bone anchors or other methods of securing a sling. A difficulty that contributes to the unnatural positioning of the urethra is that some attachment sites, such as the rectus abdominus fascia or the top of the pubic bone, require very long sutures. Long sutures increase the difficulty in achieving the proper tension in the sutures and sling and increase the chances that intervening anatomical structures may interfere with proper tension. Improper sling tension or sling suture tension can result in increased lateral movement and momentum of the support structures or mesh sling when they are moved due to intra-abdominal pressures.
U.S. Pat. No. 5,863,315 discloses a method of tensioning a suspended tissue mass. The method utilizes a suture tensioner comprising a handle, a main body and an annular recess.
More than a year prior to the filing date of the present application, Vesica Sling Kits were sold (by Boston Scientific, Microvasive, USA) in the United States that included a Suture Spacer. Surgeons were instructed to place the Suture Spacer on the top of the pubic tubercle (which is a location remote from the sling and remote from the urethra, vagina and bladder neck). The surgeon then places a suture about the Suture Spacer and ties a knot. As a knot is tied, the Suture Spacer is pulled downward onto the top of the pubic bone. Six or seven additional throws are tied and the Suture Spacer is withdrawn.
U.S. Pat. No. 5,474,518 discloses a device for correcting urinary incontinence by use of vesical suspension. The device includes a box that houses a drum with a toothed wheel that engages a worm gear.
U.S. Pat. Nos. 4,938,760 and 4,969,892 disclose a method of suspending the urethrovesical junction in females. An anchoring means for anchoring a suture in tissue is disclosed. The anchoring means comprises a rotating spool, a driving gear and an adjusting means.
PCT International Pub. No. WO 01/39670 discloses an implantable support sheet for providing suburethral stabilization for female patients. A clip is disclosed that inhibits folding of a central part of the sheet about its longitudinal axis.
U.S. Pat. No. 6,106,545 discloses a suture tensioning and fixation device for attachment of tendon to muscle or reattachment of ligaments to bone. The device includes a retaining element and suture thread engaging portions.
U.S. Pat. No. 6,117,067 discloses a device for the height-adjustable fixing and support of internal organs. The device includes a sling, threads, tube, small capsule and chamber. A needle is used to introduce or extract liquid.
U.S. Pat. No. 6,068,591 discloses an apparatus for treatment of female stress urinary incontinence with a support harness. The patent discloses an adjustable setting and Carter pin.
The present invention is directed to an article useful in surgical procedures. The article assists surgeons in providing consistent, repeatable relationships between implantable materials such as slings, and target tissue such as urethra tissue. In use with a plurality of different surgeons and a plurality of different patients, the present invention can contribute to consistent, repeatable medical results, more reliable medical data and improved medical decisions.
The article comprises a portion adapted to be grasped, and at least one tensioning member that is sized and shaped to afford predetermined looseness of an anatomical support material, such as a sling, relative to anatomical tissue, such as a urethra.
A variety of procedures are contemplated, including, for example, pubovaginal sling procedures. The present invention is particularly suitable for use in a sling procedure that places a sling in a therapeutically effective position. Preferably, the sling is placed to control the pressure applied to the urethra to obtain or restore normal anatomy and continence.
In a preferred embodiment, the article comprises a plurality of tensioning members. In one embodiment the article includes movement means for moving at least one tensioning member between an open position for receiving the anatomical support material and a closed position that associates the article with the anatomical support material. Preferably, the movement means comprises means for affording substantial parallel movement between tensioning members to resist wrinkling of the anatomical support material.
In another preferred embodiment, the plurality of tensioning members are arranged to afford a plurality of tortuous paths of different lengths, and the anatomical support material may be associated with the article along one of the tortuous paths.
In another embodiment, the article includes means for moving at least one of the tensioning members relative to another tensioning member to change the length of a tortuous path.
In another aspect, the present invention comprises a device for applying tension to a surgical sling.
In another aspect, the invention comprises a tensioning device comprises a base member having a plurality of tensioning members extending outwardly from the base member, thereby creating a tortuous pathway for sling material positioned thereon. When the sling material is used in a pubovaginal sling procedure, the tensioning device provides additional tensioning support to the urethral body, the bladder neck, or both.
The tensioning device of the present invention may have a number of different configurations. For example, in one embodiment, the base member is arcuate. In an alternate embodiment, the base member is rectangular. Additionally, the base member may include a directional indicator to aid the user in applying the device. In yet another embodiment, the base member may include an integral or detachable grasping member. The base member may further include at least one sling material locking member having an open position which allows removal of the sling material from the device, and a closed position to the retain sling material within the device.
The tensioning members of the present invention may comprise a plurality of configurations, including circular members, oval members, or other shaped members capable of retaining material disposed therein. Similarly, the tensioning members may be manufactured from a plurality of materials including, without limitation, silicone elastomer, acetate, acetal polyurethane, acrylic, elastomer, stainless steel, polysulfone, nylon, polycarbonate, polyethermide, acetal, ABS, bioresorbable materials or other biologically-compatible materials for temporary or permanent implantation.
In another form, the device remains implanted and can be adjusted in the subsequent post operative period by removing all or some of the tensioning members or by constructing the tensioning members of a bioresorbable material.
Additionally, the tensioning members may be constructed so that they indicate the preload on the sling through a deflection or alignment of the tensioning members.
The present invention may further include various methods of using the tensioning device for creating and using a tortuous pathway to apply tensioning force to a material disposed therein.
In another aspect, the present invention comprises a method of providing a uniform distance between the urethra and a sling comprising: providing a sling and tensioning article, associating the tensioning article with the sling, implanting the sling and associated tensioning article in a position substantially adjacent or, alternatively, just touching the urethra, and then removing the tensioning article. Optionally, the step of providing a sling and tensioning article includes the step of providing an insertion sheath surrounding the sling; and the step of associating the tensioning article with the sling includes the step of associating the sling and sheath combination with the tensioning article.
In another aspect, the present invention comprises a method of treating incontinence comprising the steps of: (i) providing a support material with at least a portion that is elastically deformable, (ii) elastically deforming at least a portion of the support material to tension the support material; (iii) providing a tensioning article, (iv) applying the tensioning article to the tensioned support material to retain at least a portion of the support material in an elastically deformed condition; (v) implanting the support material with applied tensioning article in a patient; removing the tensioning article to increase the tension provided by the support material.
In another method, the present invention comprises a method of reducing the looseness of an implanted sling comprising the steps of: providing a tensioning article, and associating the tensioning article with the sling in vivo to tighten the sling.
In another method, the tensioning member remains implanted and provides an elastic stress relieving component to the sling in the immediate or long term post operative period. This is particularly useful when the sling is made of an elastic material such as a silicone elastomer.
In another aspect, the present invention comprises a kit for treating incontinence. The kit comprises surgical articles for implanting a surgical sling, and a tensioning article.
Other features and advantages of the present invention will become apparent from a consideration of the following detailed description.